Clinical Study of a Low-Cost HPV Test with Same-Day Treatment to Improve Cervical Cancer Screening in Women Ages 30 to 59

What this Trial Is About

Cervical cancer rates have dropped significantly in high-income countries due to prevention strategies, but low- and middle-income countries still bear most of the global burden, with about 85% of new cases and 90% of deaths. Screening is vital to reduce this burden, and the World Health Organization recommends human papillomavirus HPV testing as the best method. However, HPV testing can be costly and complex, often requiring women to return for results and treatment, which leads to many being lost to follow-up, especially in resource-limited settings. This study evaluates a same-day screen-and-treat approach using a low-cost HPV test called ScreenFire, compared to the standard two-visit approach, in El Salvador. Women will self-collect samples for HPV testing, and if needed, receive treatment on the same day. The study will enroll 1,000 women aged 30 to 59 years from remote areas over 10 to 15 weeks to see if the single-visit method reduces loss to follow-up. Participants will be followed for six months to measure how many return for care, with the main focus on the proportion lost to follow-up at six months. The study includes assessments of adherence to the screening program and the feasibility of local processing of the HPV test. The research team will monitor outcomes related to the effectiveness of the single-visit screening and treatment strategy, aiming to improve cervical cancer prevention in low-resource settings.

Single Visit Clinical Validation of ScreenFire, a Low-Cost HPV Test: Efficacy and Cost Effectiveness (Phase 2)